Publication:

Evaluation of propranolol, flunarizine and divalproex sodium in prophylaxis of migraine

Background Preventive treatment has an important role in the management of migraine. Propranolol and flunarizine have been used for more than two decades while, open-label, controlled studies suggest divalproex sodium may also be efficacious for migraine prevention. The objective of the study to compare efficacy and safety of propranolol, flunarizine and divalproex sodium in patients for migraine prophylaxis.

Methods Following approval from IEC a 12-week randomized, open, comparative study was carried out at the outpatient department of Medicine. Patients between 18 to 65 years, with history of 3 to 12 migraines a month (IHS) for six months were included. Patients were divided into three groups of 30 patients to receive - propranolol 20 to 160mg/day; flunarizine 5 to 10mg/day or divalproex sodium 250 to 750mg/day, for three months.

Results Total 90/116 patients completed the study. No significant differences were found between the groups with regards to mean age or other baseline migraine features. All the drugs significantly decreased the frequency, duration and severity of migraine (P<0.001). There is no statistically significant difference between propranolol, flunarizine and divalproex sodium for any of the efficacy parameters. All the three treatments were well-tolerated and safe.

Conclusions All the three study drugs were equally effective with an acceptable tolerability profile, Divalproex sodium group showed more side effects, none of which were serious. However, further studies with larger number of patients and longer duration of treatment are recommended.